P & L Developments, LLC has recalled 4,752 cartons of Nicotine Polacrilex Gum USP (2 mg) because the package insert included with the product was meant for the Canadian market and does not match the approved U.S. labeling. This recall affects 110-count cartons of the Rite Aid brand nicotine gum distributed in New York and Maryland. While the gum itself is not defective, the provided instructions and safety information are not correct for U.S. consumers. If you have this product, you should contact your healthcare provider or pharmacist for guidance on proper use and return any unused product to the place of purchase for a refund.
The package insert contains labeling intended for a different country, which may provide incorrect instructions, safety warnings, or dosage information that does not align with FDA-approved standards for the United States.
Healthcare consultation and pharmacy refund
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Sources: FDA iRES · Raw API Response
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